Kornimate/medical-research-clean huggingface dataset:
influence of taping on postural control in subjects with chronic ankle instability

Conditions: Chronic Ankle Instability

Summary: the main goal of this study is to evaluate the effect of taping on postural control during dynamic exercises. 30 subjects with chronic ankle instability (cai) will be included in the study. several questionnaires regarding anthropometric data, medical history, activity level and functional status will be filled in by the participants. postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics. subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they have to maintain their balance for 10 seconds after landing. 5 good trials of each movement will be captured. subjects with cai will perform these exercises with and without tape. hypothesis is that subjects with cai that tape will enhance postural control.


Eligibility criteria:
inclusion criteria: * a history of at least one ankle sprain which resulted in pain, swelling and stiffness, prohibiting participation in sport-, recreational or other activities for at least 3 weeks * repeated ankle sprains * presence of giving way * feeling of weakness around the ankle * a decreased functional participation (recreational, competitive or professionally) exclusion criteria:
effectiveness of different remineralizing strategies on the management of early carious lesions in primary teeth

Conditions: White Spot Lesion

Summary: the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. the secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.

the primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with mi varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. the study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): mi varnish and test group 2 (n=22) :curodont repair fluoride plus. each material is applied once every 2 weeks for 3 times (intensive mode of application). the secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.

Eligibility criteria:
inclusion criteria: 1. healthy children 2. age range 3-6 3. at least 2 early carious lesions exclusion criteria: 1. children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases. 2. application of fluoride varnish less than 3 months prior to study treatment. 3. any metabolic disorders affecting bone turnover. 4. concurrent participation in another clinical trial. 5. patients receiving any antibiotic within 1 month prior to plaque sample collection

Keywords: curodont repair fluoride plus cpp-acpf sodium fluoride varnish guided enamel regeneration
nissen versus dor hiatal hernia repair

Conditions: Hiatal Hernia; Paraesophageal Hernia; Recurrence

Summary: hiatal hernia can present with a wide range of symptoms. an usual surgical repair technique usually includes nissen fundoplication, while other procedures are less frequently employed. however, recurrence and reoperation rates remain high. this randomized controlled trial aims to compare the efficacy of nissen and dor fundoplication in preventing hiatal hernia recurrence and reducing the risk of reoperation participants undergoing minimally invasive hiatal hernia repair will be randomly assigned to either nissen or dor fundoplication. postoperatively at 12 months, anatomical recurrence rates based on computed tomography scans and symptomatic recurrence rates, anti-reflux medication use, gerd-related quality of life, and dysphagia symptoms will be assessed. a subsequent long-term follow-up study will conducted afterwards utilizing national registry data to evaluate reoperation rates and anti-reflux medication use


Eligibility criteria:
inclusion criteria: * at least 18 years of age * type ii-iv hiatal hernia, confirmed by radiology or endoscopy * scheduled for mini-invasive hiatal hernia repair * emergency mini-invasive surgery for hiatal hernia * the informed consent is acquired exclusion criteria: * recurrent hiatal hernia * need for esophageal lengthening procedure (collis) * gangrene or need for any resection during (emergency) surgery * need for laparotomy or thoracotomy/thoracoscopy * no written consent
hizentra® in inflammatory neuropathies - phenix study

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy

Summary: the phenix study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for hizentra® and the methods for switching from the iv to sc route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (pro: patient-reported outcomes).

chronic inflammatory demyelinating polyneuropathy (cidp) is a neurological and rare type of autoimmune disorder. intravenous immunoglobulin (ivig) is the first-line treatment for cidp which has been proven to be effective. for several years, published cases have suggested that the sub-cutaneous ig (scig) may be an alternative treatment to ivig in the treatment of cidp. compared to ivig treatment, the scig can achieve more stable plasma igg concentrations, suggesting a potential reduction in the dose exhaustion effect at the end of the cycle, but also fewer systemic effects. sc administration also enables more straightforward treatment to be given for ambulatory patients. based on the path study (nct01545076), a double blind placebo-controlled, randomised, prospective, international multicentre phase iii study, hizentra® obtained an extension of its marketing authorization for the cidp indication as maintenance treatment after stabilisation with ivig. however, in the "real-life" situation, the literature is still based at present on small series of patient or short-term follow-up periods. however, the methods for switching from the iv to the sc route and the characteristics of patients receiving this treatment are not known. in addition, scig administration remote from a specialist centre without assistance from a health professional no longer enables a more regular assessment of the patient in terms of tolerability and efficacy. the phenix study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for hizentra® and the methods for switching from the iv to sc route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (pro: patient-reported outcomes). the study duration is estimated to be 36 months in view of: a 24-month inclusion period and a 12-month follow-up period.

Eligibility criteria:
inclusion criteria: * adult patient (aged ≥18 years) * patients suffering from cidp according to ean/pns 2021 criteria * planned switch from ivig to hizentra® * patient treated with at least 3 courses of iv immunoglobulin and deemed by the investigator to be dependent on immunoglobulins * patient deemed to be stable, with no change in their treatment for the disease during the 3 months prior to inclusion * patients who have a smartphone, a tablet or a computer * patients who have been informed verbally and in writing of the purposes of the study exclusion criteria: * concomitant participation in an interventional clinical study

Keywords: cidp igpro20 hizentra subcutaneous immunoglobulins
efficacy and safety of the investigational device, surgishield anti-adhesion barrier gel

Conditions: Wound Healing

Summary: this clinical trial is intended to evaluate the impact, efficacy, and safety of chitosan formulated adhesion inhibitor, surgishield when used in the process of wound healing after endoscopic sinus surgery.


Eligibility criteria:
inclusion criteria: * older than 21 years of age * both side sinusitis * will undergo endoscopic sinus surgery * volunteers with informed consent and signature exclusion criteria: * suppressed immunity patient * systemic grave condition * pregnant * cancer * severe disease patients * asthma patients * aids * cystic fibrosis * ciliary immobility syndrome * neutropenia neutrophil * immunoglobulin deficiency * wound healing immune disease * severe liver disease * severe kidney disease * lymph or blood clotting disorder or patients treated with coagulants * patients taking oral or parenteral glucose for diabetes thrombocytopenia * infectious disease * currently lactating * severe septal deviation * case where there is a severe difference in sinusitis state between sides of nose: there is a 3 or more score difference on the lund-mackey ct scan scoring system pns(paranasalsinus) * shellfish allergy * food allergy * had endoscopic sinus surgery in the past * patient with large sinus polyps * patients who have received treatment for extrasinus complication

Keywords: investigational device (chitosan gel) wound healing endoscopic sinus surgery surgishield
impact of col7a1 gene therapy on scc recurrence in rdeb skin

Conditions: Squamous Cell Carcinoma

Summary: the study objective is to see if bvec induced c7 expression in recessive dystrophic epidermolysis bullosa (rdeb) skin following squamous cell carcinoma (scc) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence. prevention of scc's in the rdeb subjects will increase their life span.


Eligibility criteria:
inclusion criteria: 1. diagnosis of generalized recessive dystrophic epidermolysis bullosa (rdeb) demonstrated by col7a1 mutations 2. presence of biopsy proven squamous cell carcinoma (scc) 3. ability to understand and the willingness to provide written informed consent. 4. us based participants are willing to use beremagene geperpavec (bvec) 5. subject is 18 years or older 6. participant willingness to use an effective method of contraception exclusion criteria: 1. inability to travel to site for study visit 2. subject is pregnant 3. subject has metastatic scc's or is on any current systemic treatment for scc.

Keywords: gene therapy
heparin-induced thrombocytopenia - retrospective analysis of data on incidence and outcomes study

Conditions: Heparin Induced Thrombocytopenia

Summary: hit-radio is a study of patients who had a positive heparin pf-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals. the study will collect and analyse information that is already in the patients' medical records. information about laboratory values (such as platelet counts), treatments (such as medications), and outcomes (such as blood clots, amputation, and death) will be included.

hit-radio is a retrospective chart-review study of patients who had a positive heparin pf-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals associated with the transfusion medicine/hemostasis clinical trials network . heparin-induced thrombocytopenia (hit) is a major complication of the administration of heparin and can result in life-threatening thrombosis with or without thrombocytopenia (hit-t) or can produce thrombocytopenia without clinically symptomatic thrombosis ("isolated" hit). isolated heparin-induced thrombocytopenia is defined as a fall in platelet count associated with a positive heparin pf-4 antibody test, in the absence of clinically overt thrombosis. while the treatment of hit-t (hit with thrombosis) with anticoagulation is well established, the risks and treatment of isolated hit are unclear. it is anticipated that this data analysis will provide a current overview of the implications of a positive heparin pf-4 antibody test in clinical practice. it should determine the percentage of positive heparin pf-4 antibody tests that are associated with thrombocytopenia and thrombosis (hit-t) or "isolated" hit at diagnosis and the subsequent major clinical outcomes of death, limb amputation/gangrene, and new thrombosis. no "snapshot" of such hit patients has been conducted in the past decade and the results will be important in assessing the impact of hit in current medical care as well as documenting current treatment strategies.

Eligibility criteria:
inclusion criteria: * all subjects with a positive heparin pf-4 antibody test occurring between 1/21/2008 and 9/25/2008 * medical record available for the admission during which the positive heparin pf-4 antibody test was obtained exclusion criteria: * none

Keywords: thrombocytopenia heparin
phase i study of intrathecal topotecan

Conditions: Leukemia; Lymphoma; Meningeal Neoplasms

Summary: the purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase i inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy).

the purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase i inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). a safe dose of topotecan that can be recommended for intrathecal administration in subsequent phase ii studies will be established in a limited dosage escalation schedule. the csf pharmacokinetics of intrathecal topotecan will also be studied. topotecan will be administered intrathecally on a bi-weekly basis for four to six weeks, followed by weekly administration for 1 month, twice monthly administration for four months and then monthly it administration.

Eligibility criteria:
disease characteristics: leukemia, lymphoma, or solid tumor with overt meningeal involvement considered refractory to conventional therapy. csf leukemic cell count at least 5 per cubic millimeter with evidence of blast cells on cytospin or cytology required for leukemia and lymphoma patients. tumor cells on cytospin or cytology or measurable meningeal disease on ct or mri required for patients with solid tumors. no clinical evidence of obstructive hydrocephalus or compartmentalization of the csf flow as documented by indium-111- or technetium-99-dpta flow study. prior/concurrent therapy: at least 1 week since cns therapy. biologic therapy: recovery from toxic effects of prior immunotherapy required. chemotherapy: recovery from toxic effects of prior chemotherapy required. no concomitant therapy to treat meningeal malignancy (intrathecal or systemic). concomitant chemotherapy to control systemic disease or bulk cns disease allowed except: investigational agents. agents that penetrate the cns (e.g., high-dose methotrexate, thiotepa, high-dose cytarabine, fluorouracil, intravenous mercaptopurine). agents known to have serious unpredictable cns side effects. endocrine therapy: not specified. radiotherapy: recovery from toxic effects of prior radiotherapy required. patient eligible if flow restored following focal radiotherapy to the blockage site. surgery: not specified. patient characteristics: age: 3 and over (older patients giving consent will be enrolled before the very young, if possible). performance status: ecog 0-2. life expectancy: at least 8 weeks. hematopoietic: see disease characteristics. hepatic: bilirubin less than 2.0 mg/dl, sgpt less than 3 times normal. renal: creatinine less than 1.5 mg/dl. metabolic: serum electrolytes (including calcium and phosphate) normal. other: no significant systemic illness (e.g., infection). not pregnant or lactating.

Keywords: intraventricular meningeal malignancy nsc 609699 skf 104864 topoisomerase 1
determinants of thyroid surgery outcomes

Conditions: Thyroid Disease

Summary: in a large prospective cross-sectional study, the investigators aimed to identify the determinants of thyroid surgery outcomes and quantify the relative influence of preoperative and intraoperative factors. for this purpose, the investigators considered the interplay of several characteristics specific to surgeons, patients, and surgical procedures.


Eligibility criteria:
inclusion criteria: - all patients who underwent a thyroid procedure between april 2008 and july 2008. exclusion criteria: - participation refusal

Keywords: thyroid surgery surgical outcomes patient safety healthcare quality surgeons performance
effective rehabilitation of patients operated with total knee arthroplasty

Conditions: Osteoarthritis

Summary: the purpose of this study is to investigate the effect of maximal strength training (mst) compared to standard rehabilitation in patients operated with total knee arthroplasty. previous studies report reduced physical function and muscle strength despite successful surgery inserting an artificial implant. furthermore, great loss of muscle strength has been found in these patients in the early postoperative phase. the study is a randomized controlled trial. the investigators hypothesize that mst will increase muscle strength and physical function more than standard rehabilitation.


Eligibility criteria:
inclusion criteria: * unilateral osteoarthritis, * \< 75 years exclusion criteria: * disease(s) that compromise testing/training, * unable to understand written and verbal instructions and information, * osteoarthritis in the contralateral leg that needs treatment.

Keywords: resistance training
meningioma and embolism thrombosis risk & investigation of coagulation

Conditions: Meningeoma; Thrombembolism; Surgical Resection

Summary: despite being generally benign tumors, meningiomas are associated with an increased risk for thrombembolic complications after surgical resection. the molecular mechanisms underlying this circumstance are still unknown. in this prospective observational trial, the investigators aim to evaluate the changes in coagulation and platelet function caused by tumor resection. blood samples are obtained by patients undergoing meningioma resection before and immediately after resection to detect said changes. as a control cohort, blood samples are obtained from patients undergoing resection for glioma.


Eligibility criteria:
inclusion criteria: * patients undergoing resection for meningioma or * patients undergoing resection for glioma or * healthy controls * written consent for study participation exclusion criteria: -

Keywords: meningeoma thrombembolism tissue-factor
a monocenter prospective study to evaluate the efficacy of peripherally inserted central catheter to tunnelled central catheter with cuff in home parenteral nutrition for long-term used.

Conditions: Chronic Intestinal Failure

Summary: home parenteral nutrition (hpn) is the reference treatment for anatomic or fonctionnal chronic intestinal failure. nutritionnal catheter must follow two rules: low infection rate and be able to preserve the permeability of the central vein. today, in europeen guidelines, two types of central devices are recommended: tunnelled central catheter with cuff and implanted ports. however, their insertion is not without risk. since many years, we have seen a new generation of catheter - peripherally inserted central catheter (picc line)- which have many advantage over other central catheter. espen guidelines accept the use of picc line in short and moderate-term for hpn, but no prospective study have look for long-term used in hpn. the objective of our study is to evaluate in a prospective randomised monocenter study the no-inferiority of picc line to tunnelled central catheter with cuff for serious catheter related-complications such as infection and thrombophlebitis for patient on hpn over 1 month of duration. the secondary objectives are to: evaluate the number of patients with at least one serious complications related in 1000 days of used, the rate of minors and majors complications, number of catheter inserted, the satisfaction of patients and doctors. the study is held in chu nice and will be proposed to hospitalized patients who will need hpn. after consent, patients will be randomized to receive picc line (group a) of nutritional central catheter with cuff (group b). echography of vessels will be held at the beginning, 3 months and 12 months. follow-up will be conduct at regular interval (month 0-1-3-6-9-12). the duration of follow-up will be of 12 months and the global duration of the study will be 36 months. one major complication will conduct to withdrawal of the study. there will be 55 patients in each group.


Eligibility criteria:
inclusion criteria: * \> 18 years-old * patients managed by chu nice for home parenteral nutrition * expected to have over 1 month of parenteral nutrition * signed consent * affiliation to securite social exclusion criteria * patient with nutritional catheter before inclusion * pregnancy or breastfeeding * evolutive pathology with life expectancy \< 12 months
effectiveness of an mhealth colorectal cancer screening intervention

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to determine whether a multilevel mhealth intervention (mcrc) can increase the percentage of patients who receive colorectal cancer screening. the mcrc intervention will include a tablet-based patient education program, clinic protocols to facilitate the ordering of crc screening tests, and electronic messaging with patients to promote screening. the investigators hypothesize that participants randomized to mcrc will be more likely to complete screening compared with those randomized to the control arm of the study. additionally, the investigators hypothesize mcrc will increase several intermediate outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will predict completion of screening. lastly, the investigators hypothesize the mcrc intervention will add little to the overall cost of screening.


Eligibility criteria:
inclusion criteria: * english-speaking patients aged 50 - 74 years * scheduled to see a primary care provider for a routine (i.e., non-urgent care) visit * due for colorectal cancer screening exclusion criteria: * a personal history of crc * specific crc risk factors, including: first degree relative with crc; personal history of adenomatous polyps; recent blood in stools * obvious physical or mental disability that would prevent participant from interacting with a tablet device. * receipt of treatment for cancer (excluding non-melanoma skin cancers) within the last 6 months.

Keywords: colorectal cancer screening computer-assisted instruction mhealth text message